Determine feasibility and tolerability of accelerated iTBS for postpartum depression. The investigators hope to retain >80% of recruited patients (feasibility) and reach a full treatment dose of 120%rMT in >80% of enrolled women (tolerability).

Anti-depressant effect

20

Female

18 Years to 50 Years (Adult)

NCT03417960

Pro00073886

January 24, 2018

February 1, 2019

July 1, 2019

January 31, 2018

January 31, 2018

Medical University of South CarolinaCharleston, South Carolina, United States

Effect of SAGE-217 on depressive symptoms in subjects with severe postpartum depression compared to placebo as assessed by the change from baseline in Hamilton Rating Scale for Depression (HAM-D) total score

Safety and tolerability of SAGE-217 compared to placebo as assessed by the incidence of adverse events, vital sign measurements, clinical laboratory evaluations, and electrocardiogram (ECG) parameters

Safety and tolerability of SAGE-217 compared to placebo as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)

Effect of SAGE-547 on depressive symptoms in subjects with severe postpartum depression compared to placebo injection as measured by the change from baseline in Hamilton Rating Scale for Depression (HAMD) total score

Safety and tolerability of SAGE-547 compared with placebo as measured by the change from baseline in the incidence of AEs, vital signs, clinical laboratory evaluations, and ECG parameters

Safety of SAGE-547 compared to placebo as measured by the change from baseline in suicidal ideation and behavior assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) score

Effect of SAGE-547 on depressive symptoms in subjects with moderate postpartum depression compared to placebo injection as measured by the change from baseline in Hamilton Rating Scale for Depression (HAMD) total score

Safety and tolerability of SAGE-547 compared with placebo as measured by the change from baseline in the incidence of AEs, vital signs, clinical laboratory evaluations, and ECG parameters

Safety of SAGE-547 compared to placebo as measured by the change from baseline in suicidal ideation and behavior assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) score

Effect of SAGE-547 on depressive symptoms in subjects with severe postpartum depression compared to placebo injection as measured by the change from baseline in Hamilton Rating Scale for Depression (HAMD) total score

Safety and tolerability of SAGE-547 compared with placebo as measured by the change from baseline in the incidence of AEs, vital signs, clinical laboratory evaluations, and ECG parameters

Safety of SAGE-547 compared to placebo as measured by the change from baseline in suicidal ideation and behavior assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) score

Change from baseline on maternal depression diagnosis immediately following the 3 month intervention and at 3 months post-intervention as measured by the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID)

Change from baseline in maternal depressive symptom scores immediately following the 3 month intervention and at 3 months post-intervention as measured by the Edinburgh Postnatal Depression Scale

Mother-infant interaction (videotaped and coded) immediately following the 3 month intervention and at 3 months post-intervention

(and 3 more...)

42

Female

Child, Adult, Senior

NCT02057627

1R21HD065156-01

June 2010

July 2012

July 2012

February 7, 2014

April 20, 2016

MGH Insiitute of Health ProfessionsBoston, Massachusetts, United States